NCT06766825Befejeződött2. fázis
Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)
Phase II Proof-of-concept, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 8.
Rövid összefoglaló (regiszter, angolul)
The study aims to prove that plitidepsin could be an efficacious, safe, and well-tolerated therapy for PCC. To this end, we will perform a randomized, double-blind study comparing the clinical and laboratory benefits of plitidepsin vs. placebo in 90 subjects with moderate to severe functional disability. The study consists of an intervention period and a follow-up period, with a total of 135 +/-3 days approximately between both periods. During the intervention period, four treatment cycles will be administered, scheduled every 15 days (every 2 weeks), with intravenous (IV) infusion over three consecutive days. After completing the intervention period, a 90-day (+/-5) follow-up period will be conducted. Subjects in arm A will receive the plitidepsin 1.5 mg/day 1h-IV during the four treatment periods on Days 1 to 3, Days 15 to 17, Days 29 to 31 and Days 43 to 45. Subjects in arm B will receive 1h-IV placebo 1 vial /day during the first two treatment periods and will receive the plitidepsin 1.5 mg/day 1h-IV during the last two treatment periods. Subjects in arm C will receive 1h-IV placebo 1 vial/day during the four treatment periods.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tényleges)
- Első benyújtás
- 2024. dec. 31.
- Kezdés
- 2025. febr. 7.
- Elsődleges befejezés
- 2026. szept. 29.
- Fő szponzor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Betegségek
- Long COVID és ME/CFS
- NCT-szám
- NCT06766825
- EU CT-szám
- 2024-516378-31-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Bevont résztvevők: 90
- 2025. febr. 7. és az elsődleges befejezés (2026. szept. 29.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Last SARS-CoV-2 vaccine dose during the previous 30 days.
- Patients infected by SARS-CoV-2 virus in the last 90 days prior to the screening visit.
- Patients receiving treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers (Annex 1) throughout plitidepsin treatment period and until 24-h washout period.
- Pacients receiving chronic glucocorticoid therapy (high-dose corticosteroids [ie, 20 mg of prednisone daily or equivalent for ≥2 weeks)
- Currently participating or participated in a clinical trial within the prior
Más betegség
- Patients with active uncontrolled infections.
- Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or contraindication to receive systemic glucocorticoids, antihistamine H1/H2 receptor agents, or antiserotonine 5HT3 receptors drugs.
- Mast cell activation syndrome.
Laborértékek
- Any of the following cardiac conditions or risk factors:
- Cardiac infarction or cardiac surgery episode within the last six months 14
- History of known congenital QT prolongation;
- Known structural cardiomyopathy with abnormal left ventricular ejection fraction (LVEF) <50%;
- Current clinical evidence of heart failure or acute cardiac ischaemia (New York Heart Association (NYHA) class III-IV).
- Females who are pregnant (negative serum or urine pregnancy test required for all females of childbearing potential at screening) or breast-feeding.
Egyéb
- Females of childbearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using highly effective contraceptive methods, while on study treatment and for 6 months after last dose of plitidepsin. Fertile males with partners of childbearing potential must use condom during treatment and for 6 months after last dose of plitidepsin. Refer to Annex 2 for contraception requirements.
- Unable to consent and/or comply with study requirements, in the opinion of the investigator.
A regiszterben nem jelölt feltételek
- Male or female individuals 18 years old or older.
- Evidence of SARS-CoV-2 infection at least 90 days prior to study recruitment, defined by either (a) nasopharyngeal SARS-CoV-2 nucleic acid test [polymerase chain reaction (PCR) or transcription mediated amplification (TMA)], (b) validated Nasopharyngeal Lateral Flow Assay rapid antigen test (RAT), or (c) or positive serology against SARS-CoV-2 N protein regardless vaccination status.
- 3 or more symptoms of PCC affecting at least two organs, after 90 days from the onset of SARS-CoV2 infection and that last for at least 2 months and cannot be explained by an alternative diagnosis. Symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms may also fluctuate or relapse over time.
- Unable to perform all usual duties/activities, defined as grades 3 or 4 in PCFS (Annex 3).
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- Having understood the information provided and capable of providing informed consent
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Spanyolország | Befejeződött |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.